Staloral Allergen of birch pollen, maintenance course, vial 10ml 5pcs

Composition

of sublingual drops

Active Ingredient:

Allergen extract from birch pollen 10 IR / ml*,300 IR / ml

Auxiliary substances:

sodium chloride,

glycerol,

mannitol,

purified water * IR / ml-Reactivity Index-biological unit of standardization.

Pharmacological action

The exact mechanism of action of the allergen during allergen-specific immunotherapy (ASIT) is not fully understood. The following biological changes are proven: :

• the appearance of specific antibodies (IgG4) that play the role of “blocking antibodies”;
• a decrease in the level of specific IgE in plasma;
• a decrease in the reactivity of cells involved in an allergic reaction;
• an increase in the activity of the interaction between Th2 and Th1, leading to a positive change in the production of cytokines (a decrease in IL-4 and an increase in -interferon) that regulate IgE production.

ASIT also inhibits the development of both the early and late phases of an immediate allergic reaction.

Indications

Allergen-specific immunotherapy (ASIT) for patients with type 1 allergic reaction (IgE-mediated), rhinitis, conjunctivitis, mild or moderate seasonal bronchial asthma, and hypersensitivity to birch pollen.

Immunotherapy can be performed for adults and children from the age of 5 years.

Contraindications

• Hypersensitivity to one of the excipients (see the list of excipients);
• Autoimmune diseases, immunocomplex diseases, and immunodeficiency disorders; 
• Malignant neoplasms;
• Uncontrolled or severe bronchial asthma (forced expiratory volume < 70%);
• Beta-blocker therapy (including topical therapy in ophthalmology);
• Severe inflammatory diseases of the oral mucosa, for example, erosive and ulcerative form of lichen planus, mycoses.

Side effects

ASIT may cause both local and general adverse reactions. The dosage and treatment regimen may be reviewed by the attending physician in the event of an individual reaction or changes in the general condition of the patient.

Local reactions:

• oral: itching in the oral cavity, swelling, discomfort in the mouth and throat, impaired salivary glands (increased salivation or dry mouth);
• gastroenterological reactions: abdominal pain, nausea, diarrhea.

Usually, these symptoms go away quickly, and there is no need to change the dosage and treatment regimen. In case of frequent occurrence of symptoms, the possibility of continuing therapy should be reviewed.

General reactions are rare:

• rhinitis, conjunctivitis, asthma, and urticaria require symptomatic treatment with H1 antagonists, beta-2 mimetics, or oral corticosteroids. The doctor should review the dosage and treatment regimen or the possibility of continuing ASIT.
• in extremely rare cases, generalized urticaria, angioedema, laryngeal edema, severe asthma, anaphylactic shock are possible, which requires the withdrawal of ASIT.

Rare side effects not related to Ig-E mediator reactions:

• asthenia, headache;
• exacerbation of preclinical atopic eczema;
• delayed reactions of the type of serum sickness with arthralgia, myalgia, urticaria, nausea, adenopathy, fever, which requires the withdrawal of ASIT.

All side effects should be reported to your doctor.

Interaction

Do not use at the same time as taking beta-blockers.

 Concomitant use with symptomatic anti – allergic drugs (H1-antihistamines, beta-2-mimetics, corticoids, mast cell degranulation inhibitors) is possible for better tolerability of ASIT.

How to take, course of use and dosage

The effectiveness of ASIT is higher in cases where treatment is initiated in the early stages of the disease.

Dosage and treatment regimen The dosage of the drug and the scheme of its use are the same for all ages, but can be changed depending on the individual reactivity of the patient.

The attending physician adjusts the dosage and treatment regimen in accordance with possible symptomatic changes in the patient and individual response to the drug.

It is advisable to start treatment no later than 2-3 months before the expected flowering season and continue throughout the entire flowering period.

Treatment consists of two stages: initial and maintenance therapy. 1. Initial therapy begins with a daily dose of the drug at a concentration of 10 IR/ml (blue bottle cap) with a single tap on the dispenser and gradually increases the daily dosage to 10 taps. One tap on the dispenser is about 0.1 ml of the drug. Then proceed to the daily intake of the drug at a concentration of 300 IR/ml (purple bottle cap), starting with a single tap and gradually increasing the number of taps to the optimal one (well tolerated by the patient). The first stage can last 9-21 days. During this period, the maximum dosage is reached, individual for each patient (from 4 to 8 taps daily of the drug at a concentration of 300 IR/ml), after which they proceed to the second stage.

2. Maintenance therapy with a constant dose using a vial of 300 IR/ml. The optimal dose achieved at the first stage of initial therapy is continued to be taken at the second stage of maintenance therapy. Recommended dosage regimen: 4 to 8 taps on the dispenser daily or 8 taps 3 times a week. Duration of treatment Allergen-specific immunotherapy is recommended to be carried out in the above two-stage courses (2-3 months before the expected flowering season before the end of the season) for 3-5 years. If after treatment, improvement did not occur during the first flowering season, the expediency of ASIT should be reviewed. Method of application Before taking the drug, make sure that:

• the expiration date has not expired; 
• use a bottle of the desired concentration.

The drug is recommended to be taken in the morning before breakfast. The drug should be dropped directly under the tongue and held for 2 minutes, then swallowed. Children are recommended to use the drug with the help of adults. To ensure the safety and security of the drug, the vials are hermetically sealed with plastic lids and rolled with aluminum caps.

When using it for the first time, open the bottle as follows:  1 / Tear off the colored plastic cap from the bottle.

2 / Pull on the metal ring, removing the aluminum cap completely.

3 / Remove the rubber stopper.

4 / Remove the dispenser from its plastic packaging. Hold the bottle firmly in one hand, and with the other hand, press hard on the top flat surface of the dispenser, snap it on the bottle.

5 / Remove the orange protective ring.

6 / Press the dispenser firmly 5 times over the sink. After five taps, the dispenser dispenses the required amount of the drug.

7 / Place the tip of the dispenser in your mouth under your tongue. Press the dispenser hard as many times as your doctor has prescribed to get the right amount of the drug. Hold the liquid under your tongue for 2 minutes.

8 / After use, clean the dispenser tip and put on the protective ring. For subsequent use, remove the protective ring and follow steps 7 and 8. Take a break from taking the drug

If you miss taking the drug for a long time, you should consult your doctor. If you missed taking the drug for less than one week, it is recommended to continue treatment without changes.

If the drug is missed for more than one week at the initial stage or during maintenance therapy, it is recommended to start treatment again with a single tap on the dispenser, using the same concentration of the drug (as before the break), and then increase the number of taps, according to the scheme of the initial stage of therapy, to the optimal well-tolerated dose.

Overdose

If the prescribed dose is exceeded, the risk of side effects increases, which requires symptomatic treatment.

Active ingredient

Birch pollen allergen

Conditions of release from pharmacies

By prescription

Dosage form

oral drops